Seven Bodies That May Request Withdrawal: Article 40 of Executive Decree No. 20-324

1. Key takeaways

Article 40 of Décret exécutif n° 20-324 lists seven categories of bodies that may request the withdrawal of a homologation decision:

the Minister of Pharmaceutical Industry; the Minister of Health; the holder or the operator of the homologation decision; the National Agency for Pharmaceutical Safety; national bodies under the Ministry of Health; the pharmaceutical regulatory authorities of other countries as well as Algeria’s own; and the materiovigilance body.

The significance of this list is that a withdrawal is not necessarily initiated by ANPP itself. Competition regulators, notifications from abroad, and even the holder or operator on its own initiative can all set the procedure in motion.

2. Legal basis

1. Décret exécutif n° 20-324 du 6 Rabie Ethani 1442 correspondant au 22 novembre 2020 relatif aux modalités d’homologation des dispositifs médicaux (Executive Decree No. 20-324 of 6 Rabie Ethani 1442 corresponding to 22 November 2020 on the modalities of homologation of medical devices, JORADP No. 69, published on 22 November 2020, pages 10–14, 46 articles in total), Article 40 (the seven categories of bodies that may request withdrawal), Article 41 (cessation of distribution and disposal of batches) and Article 42 (information notification).
2. Décret exécutif n° 20-324 du 6 Rabie Ethani 1442 correspondant au 22 novembre 2020 relatif aux modalités d’homologation des dispositifs médicaux (JORADP No. 69, published on 22 November 2020, pages 10–14, 46 articles in total), Article 38 (temporary withdrawal of up to 12 months) and Article 39 (lifting or conversion into definitive withdrawal).
3. Arrêté du 28 Ramadhan 1442 correspondant au 10 mai 2021 fixant la composition du dossier d’homologation et du dossier de renouvellement de la décision d’homologation des dispositifs médicaux à usage de la médecine humaine (Order of 10 May 2021 fixing the composition of the homologation dossier and the renewal dossier of the homologation decision for medical devices intended for human medicine, JORADP No. 55, published on 14 July 2021, pages 21–24, 13 articles in total), Article 46 (the materiovigilance summary is a required element of the renewal dossier).
4. Décret exécutif n° 21-82 du 11 Rajab 1442 correspondant au 23 février 2021 relatif aux établissements pharmaceutiques et les conditions de leur agrément (Executive Decree No. 21-82 of 23 February 2021 on pharmaceutical establishments and the conditions of their approval, JORADP No. 14, published on 28 February 2021, pages 9–12, 29 articles in total), Article 5 (establishments must comply with pharmacovigilance and materiovigilance requirements) and Article 9 (operating establishments carry out materiovigilance operations).

3. Expert insights

Insight 1: the holder and the operator are themselves on the list of requesting bodies.

The third category of Article 40 expressly includes the holder and/or the operator of the homologation decision. This means a company may apply for withdrawal of its own decision — when a product line is being retired, upgraded, or cannot be supplied continuously, a voluntary withdrawal is far more controllable than a forced one, because the company chooses the timing and controls the communication around it.

Insight 2: regulators at home and abroad can both trigger withdrawal, which shows Algeria is plugged into the international vigilance network.

The sixth category of Article 40 lists the pharmaceutical regulatory authorities of Algeria and of other countries side by side. A single recall in the country of origin, or in a third country, can therefore travel through this channel and become an Algerian withdrawal procedure. This also explains why Article 36 requires the declaration of “prohibitions or restriction measures of the country of origin or the countries of sale”: the two provisions are two ends of the same pipeline.

Insight 3: the materiovigilance body is an independent category, standing alongside the regulatory authorities.

The seventh category of Article 40 is the materiovigilance body (l’organisme de matériovigilance). Article 46 of the order of 10 May 2021 requires the renewal dossier to contain a summary of the materiovigilance system, which shows that the vigilance system is something the holder must build itself — while notifications from the vigilance body can, in the opposite direction, trigger withdrawal. Vigilance data thus flows both ways.

Insight 4: of the seven categories, the health and pharmaceutical-industry systems each hold two seats.

The Minister of Pharmaceutical Industry and the Minister of Health stand as the first and second categories; the National Agency for Pharmaceutical Safety and the national bodies under the Ministry of Health are the fourth and fifth. This two-ministry, four-seat structure reflects Algeria’s dual-track regulation, which balances industrial policy on one side and public health on the other — a company facing withdrawal may therefore hear from either track, sometimes with different priorities.

4. Practical recommendations

1. Treat notifications from pharmaceutical regulatory authorities, domestic or foreign, as a tier-one risk signal and bring them into routine monitoring.
2. Build the materiovigilance system in-house and keep the system summary on file, to satisfy Article 46 and the interface with the vigilance body.
3. When retiring or upgrading a product line, assess a voluntary withdrawal application, which is more controllable than a forced procedure.
4. Draw a trigger map of the seven categories under Article 40 and name the internal responder for each trigger.
5. Agree with the local operating establishment that either party must notify the other the same day it receives withdrawal-related information.
6. Review vigilance data periodically and complete the Article 46 system summary ahead of renewal.

5. Verification checklist

• □ Notifications from domestic and foreign regulatory authorities are classified as a tier-one risk signal and monitored.
• □ The materiovigilance system has been built in-house and the system summary is retained.
• □ A voluntary-withdrawal plan for product-line exits or upgrades has been assessed.
• □ A trigger map of the seven categories exists, with internal responders named.
• □ The same-day notification arrangement with the operator is written into the agreement.
• □ Vigilance data is reviewed periodically and the system summary is complete ahead of renewal.

Regulatory information verified as of 30 October 2026.

GRZAN provides post-market compliance support for the Algerian market: monitoring the seven withdrawal-request channels under Article 40, managing withdrawal and recall proceedings, operating materiovigilance interfaces, and coordinating with ANPP, the vigilance body and local operators. For support with withdrawals, recalls and inspection responses in Algeria, contact info@grzanglobal.com.